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Trial record 10 of 33 for:    "Oncology, Medical"

Transpulmonary Thermodilution Using an Implented Central Venous Access Port (ThermoD-PAC)

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ClinicalTrials.gov Identifier: NCT02357953
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:

Perioperative hemodynamic optimization requires monitoring adapted to the risks of the surgery and the patient. The investigators currently use a local hemodynamic protocol based on the data of the literature. According to this protocol, specific patients may require cardiac index and central venous oxygen saturation monitoring. the investigators chose to monitor the cardiac index (CI) with the transpulmonary thermodilution technique (TPTD) (PiCCO, Pulsion Medical System, Munich, Allemagne). The technique is based on the injection of a cooled bolus of saline into a central vein with a central venous catheter (CVC). The variation of temperature is measured with an arterial femoral catheter and allows the assessment of the cardiac output according to Stewart-Hamilton's theory. Many studies showed the reliability of this technique (Bein J Cardio Thorac Vasc Anesth 2004, Buhre Cardio thorac vasc anesth 1999, Felbinger J Clin ANesth 2005, Felbinger TW J Clin Anetsh 2002, Godie O Ann Thorac Surg 1999).

In our institute, most of the patients are fitted with a port for chemotherapy or parenteral nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be more difficult because of the port. It may be interesting to use the port for TPTD in order to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by the port was as reliable as the classical measurement with a CVC.

The aim of this study was to assess whether measurement of the CI by TPTD was possible and reliable via the port. The investigators conducted a prospective study comparing the measurement of the CI by TPTD before and after fluid challenge via the port versus the CVC.


Condition or disease Intervention/treatment
Medical Oncology Other: Measurement of cardiac index

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Cardiac Index by Transpulmonary Thermodilution Using an Implanted Central Venous Access Port: a Prospective Study in Patients Scheduled for Oncologic High-risk Surgery
Study Start Date : October 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013



Primary Outcome Measures :
  1. Assessment of the measurement of cardiac index with the transpulmonary thermodilution technique [ Time Frame: At inclusion ]
    During surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for onoclogic hish-risk surgery
Criteria

Inclusion Criteria:

  • presence of port
  • scheduled surgery with perioperative optimization requirement according to the local hemodynamic protocol
  • oral consent of the patient after oral and written information

Exclusion Criteria:

  • age inferior to 18
  • Contraindication or failure to the insertion of the CVC
  • Contraindication to the use of the port : local or general infection suspected or proved, absence of blood backflow

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357953


Locations
France
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Alexandre Eghiain, MD Gustave Roussy, Cancer Campus, Grand Paris

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT02357953     History of Changes
Other Study ID Numbers: 2012-A00003-40
2012/1386 ( Other Identifier: CSET number )
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016